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Article Biopharma Manufacturers Respond to Ebola Crisis
Demand for new therapies and vaccines spotlights production challenges. Oct 1, 2014 By: Jill Wechsler BioPharm International Volume 27, Issue 10, pp. 8-9 The development of new tr…

Article FDA Urged to Preserve Biosimilar Naming Conventions
“The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system will not benefit patients,” said Neas. “Instead, it will upset the very systems n…

Article Global Expansion Shapes Drug Oversight
In a March 2014 lecture to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), Hamburg described efforts underway to form an International Coalition of Medical Regulatory …

Article Bureaucratic Roadblocks Threaten Biopharma Growth
… health-care that millions of Indians face, but that it undermines the nation’s goal of becoming a healthcare and science innovator. There are companies around the world interested in collaborating i…

Article Monoclonal Antibodies Key to Unlocking the Biosimilars Market
mAbs are also extremely costly, and biologic versions are needed to maintain functioning healthcare systems, according to Theodor Dingermann, a professor and director of the Department of Pharmaceutic…

Article Quality by Design—Bridging the Gap between Concept and Implementation
…oduct quality officer at GSK, and Keith Pugh, expert pharmaceutical assessor at the UK Medicines and Healthcare products Regulatory Agency (MHRA), in a joint presentation on innovation (7). The barri…

Article Outsourcing Trends in Biopharmaceutical Manufacturing
Markets for biopharmaceuticals are growing in many developing countries, such as India and China, with increased incomes, a new middle class and improved healthcare. Indeed, China (8.6%) and India (8.…

Article EMA Collaborates with HTA Assessment Networks
The Impact of HTAs on Biosimilars As a result of cuts in healthcare costs due to post-recession austerity programs, favorable HTAs are becoming crucial to the successful market launch of pharmace…

Article State of Quality and Compliance in the Biopharmaceutical Industry
Stakeholders are more demanding as healthcare costs continue to skyrocket. Patients are becoming more involved and demanding about their health. Additionally, there have been several R&D disappointmen…

Article Elucidating Biosimilars Characterization
…t that is driving payers to push for wider adoption of biosimilars to manage the escalating costs of healthcare. While many companies are keen on getting a share in the biosimilars market, bringing t…

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